Veterinary Medicines

KEYTIL 300 mg/ml + 90 mg/ml solution for injection

Authorised
  • Tilmicosin
  • Ketoprofen
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Product identification

Medicine name:
KEYTIL 300 mg/ml + 90 mg/ml solution for injection
KEYTIL 300 mg/ml + 90 mg/ml solution for injection
Active substance:
  • Tilmicosin
  • Ketoprofen
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Tilmicosin
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Ketoprofen
    90.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        93
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.U.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10516/019/001
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0280/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 1/02/2024
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Package Leaflet

English (PDF)
Published on: 1/02/2024
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Labelling

English (PDF)
Published on: 1/02/2024
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eu-PUAR-esv0280001-dcp-keytil-300-mg-ml-+-90-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 1/02/2024
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